DS-3201b in Participants With Lymphomas

• Register: ClinicalTrials.gov
• Last refreshed on: 15 April 2024
• Main ID: NCT02732275
• Date of registration: 04/04/2016
• Prospective Registration: No
• Primary sponsor: Daiichi Sankyo Co., Ltd.
• Public title: DS-3201b in Participants With Lymphomas
• Scientific title: A Phase 1 Multiple Ascending Dose Study of DS-3201b in Subjects With Lymphomas
• Date of first enrolment: March 31, 2016
• Target sample size: 100
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT02732275
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

Japan, United States

Contacts

• Name: Global Clinical Leader, MD
• Affiliation: Daiichi Sankyo

Key inclusion & exclusion criteria

Inclusion Criteria:

- Has hematocytological or pathological diagnosis of non- Hodgkin's lymphoma (NHL)

- Has relapsed from or is refractory to standard treatment or no standard treatment is
available

- Is the age of majority in their country (18 in the US and 20 in Japan) at the time of
informed consent

- Has Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

- Has at least one evaluable lesion site (not applicable for the DDI cohort)

- Has preserved organ function based on baseline laboratory data at screening tests

- If of reproductive potential, agrees to avoid harvesting ova or sperm, and to use a
protocol-defined form of contraception or avoid intercourse, during and upon
completion of the study, and for at least 3 months after the last dose of study drug

- Tumor biopsy collections:

1. willing to provide archived or fresh tumor tissue samples that are sufficient for
comprehensive genomic and/or proteomic analyses at baseline

2. [US only] willing to provide fresh on-treatment tumor biopsy if deemed acceptable
risk by the investigator

[Japan only] fresh on-treatment tumor biopsy should be performed if deemed
acceptable risk by the investigator

3. willing to provide optional fresh end-of-treatment biopsy

For ATL subjects:

- Has a positive test result for human T-lymphotropic virus type I antibody

- Has ATL subtype classified as acute, lymphomatous, or chronic with poor prognostic
factor

- Has diagnosis of relapse (including relapse after partial remission [PR]) or
treatment-resistant ATL at the time of informed consent after prior treatment with at
least 1 anti-cancer medication regimen

Exclusion Criteria:

- Has been diagnosed with protocol-defined cutaneous T-cell lymphoma or T-cell leukemia.
For DDI cohort, CTCL is not exclusionary.

- Has a history or presence of central nervous system (CNS) involvement

- Has a medical history, complication or other malignancy considered inappropriate for
participation in the study, or a serious physical or psychiatric disease, the risk of
which may be increased by participation in the study

- Has received drugs or other treatments not allowed by the protocol

- History of treatment with other enhancer of zeste (EZH) inhibitors

- Has had allogeneic hematopoietic stem cell transplantation (HTCP) within 90 days
before scheduled dosing on Cycle 1 Day 1

- Is pregnant or breastfeeding

- Is otherwise deemed ineligible to participate by the investigator or sub-investigator

DDI Cohort Only:

- Has received following medications within 14 days prior to study drug administration

- Any CYP3A inhibitors/inducers including weak CYP3A inhibitors/inducers, and P-gp
inhibitors, midazolam as well as digoxin



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Lymphoma, Malignant

Non-hodgkin Lymphoma

Intervention(s)

Drug: DS-3201b

Primary Outcome(s)

Dose Escalation Period: Area under the plasma concentration time curve up to the last quantifiable time (AUClast) for DS-3201 [Time Frame: Day 1 of the first 28-day cycle]

Dose Escalation Period: Time of maximum concentration (Tmax) of DS-3201 [Time Frame: within the first 28-day cycle]

DDI cohort only: Area under the plasma concentration time curve up to the last quantifiable time (AUClast) for DS-3201,midazolam,digoxin [Time Frame: within the first 28-day cycle]

Dose Escalation Period: Maximum concentration (Cmax) of DS-3201 [Time Frame: within the first 28-day cycle]

Number of participants with treatment-emergent adverse events (TEAEs) [Time Frame: through the end of the study (within approximately 5 years)]

DDI cohort only: Area under the plasma concentration time curve during the dosing interval (AUCtau) for DS-3201, midazolam, digoxin [Time Frame: within the first 28-day cycle]

DDI cohort only: Maximum concentration (Cmax) of DS-3201, midazolam, digoxin [Time Frame: within the first 28-day cycle]

Dose Escalation Period: Trough (minimum) plasma concentration (Ctrough) [Time Frame: Day 15 of the first 28-day cycle]

Dose Escalation Period: Area under the plasma concentration time curve during the dosing interval (AUCtau) for DS-3201 [Time Frame: Day 1 of the first 28-day cycle]

Dose Escalation Period: Average plasma concentration (Cavg) [Time Frame: Day 15 of the first 28-day cycle]

Dose Escalation Period: Number of participants with dose-limiting toxicities (DLTs) [Time Frame: within 28 days after the initial dose of the study drug]

DDI cohort only: Time of maximum concentration (Tmax) of DS-3201, midazolam, digoxin [Time Frame: within the first 28-day cycle]

Secondary Outcome(s)

Disease control rate (DCR) [Time Frame: within 5 years]

Best overall response, based on international consensus criteria [Time Frame: from the start of study treatment to the end of follow-up visit (within 5 years)]

Number of participants with ATL who achieved each level of therapeutic response per international consensus standards [Time Frame: through the end of the study (within approximately 5 years)]

Number of participants with malignant lymphoma who achieved each level of therapeutic response per international consensus standards [Time Frame: through the end of the study (within approximately 5 years)]

Number of participants with CTCL who achieved response per 2011 CTCL criteria [Time Frame: through the end of the study (within approximately 5 years)]

Duration of response (DOR) [Time Frame: within 5 years]

Objective response rate (ORR) [Time Frame: within 5 years]

Progression-free survival (PFS) [Time Frame: witihn 5 years]

Secondary ID(s)

163173

DS3201-A-J101

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Daiichi Sankyo